Exploration of Continuous Glucose Monitoring on the Intensive Care Unit

NCT06645873 | Completed FDA Device

• 1 other identifier: NL87243.100.24
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

Both hyperglycemia and hypoglycemia in patients at the intensive care unit (ICU) are strongly associated with increased morbidity and mortality. Accurate and timely measurements of glucose levels in this population are therefore crucial. Continuous glucose monitoring (CGM) appears promising for this purpose, but it is not yet used in the ICU due to insufficient knowledge about its reliability in critically ill patients. The aim of this study is to investigate the discrepancy between CGM and point-of-care measurements in ICU patients and whether this discrepancy is consistent across all ICU patient groups/characteristics. This study investigates whether continuous glucose monitoring can be used in the intensive care setting.

Conditions

Hypoglycemia, Hyperglycemia

Keywords

Intensive care units; insulin; Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (2)

• Discrepancy glucose CGM - POC

  Discrepancy between glucose levels (in mmol/L) measured with Continuous Glucose Monitoring (measured with the Dexcom G7 sensor) and Point-Of-Care (measured with the Accu-check) measurement in insulin-dependent Intensive Care Unit patients. The discrepancy is defined as the difference in absolute glucose levels in arterial blood samples.

  From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.

• Variation discrepancy across patient-related factors

  The variation of the potential difference in glucose levels (in mmol/L) between CGM (measured with the Dexcom G7 sensor) and POC (measured with the Accu-check) will be analyzed among the following patient-related factors: Age at the time of inclusion (in years). Body Mass Index (BMI) (in kg/m²). Gender (Male/Female). Comorbidities: Hypertension (Yes/No). Hypotension (Yes/No). Pre-existing diabetes (Yes/No). Edema (measured as weight gain in kg). Acidosis (pH value, continuous scale). Medication use: Corticosteroids (Yes/No). Inotropics (Yes/No and dosage in µg/kg/min). Vasopressors (Yes/No and dosage in µg/kg/min). APACHE II score (Scale). SOFA score (Scale). Reason for ICU admission (Categorical variable, e.g., sepsis, trauma, etc.). Length of ICU stay (in days). Duration of mechanical ventilation (in hours or days). Dialysis (Yes/No).

  From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.

Secondary Outcomes (6)

• Adverse events

  From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.

• Number of missed hypo- and hypreglycemia episodes

  From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.

• Delay in detection hypo- or hyperglycemia episodes

  From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.

• Insertion CGM: time till reliable data and lasting time

  From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.

• Impact radiologic procedure

  From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days, but only if a radiologic procedure is performed

Study Arms (1)

Continuous glucose monitoring

EXPERIMENTAL

Device: Continuous glucose monitoring (CGM) device

Interventions

Continuous glucose monitoring (CGM) device DEVICE

All included study participants recieve a CGM sensor (Dexcom G7) to monitor blood glucose. The treatment team is blind for the CGM values; the gold standard for glucose control (POC interval measures) will be followed.

Continuous glucose monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to the ICU
• Insulin-dependent as defined in local protocol
• Age: ≥ 18 y
• Expected length of stay in ICU more than 2 days

You may not qualify if:

• Pregnancy
• No informed consent
• Therapeutic hypothermia (less than 34 degrees celsius)
• Use of hydroxyurea
• Use of acetaminophen more than 4 g/day

Sponsors & Collaborators

• Kim Kamphorst: lead
• DexCom, Inc.: collaborator
• Pioneers in Healthcare: collaborator

Study Sites (3)

Zorggroep Twente Almelo

Almelo, Overijssel, 7609 PP, Netherlands

Location

Deventer Ziekenhuis

Deventer, Overijssel, 7416SE, Netherlands

Location

Medisch Spectrum Twente

Enschede, Overijssel, 7512 KZ, Netherlands

Location

MeSH Terms

Conditions

Hypoglycemia; Hyperglycemia; Insulin Resistance

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 17, 2024
• Study Start: December 17, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)